Argatroban Plus R-tPA for Acute Ischemic Stroke

Stroke Clinical Trial

Official title:

Argatroban Plus R-tPA for Acute Ischemic Stroke: a Prospective, Random, Open Label, Blinded Assessment of Outcome Multi-center Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03740958
• Other study ID #: k (2018)45
• Status: Completed
• Phase: Phase 4
• Start date: December 21, 2018
• Est. completion date: January 30, 2022

Study information

• Verified date: February 2022
• Source: General Hospital of Shenyang Military Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Acute ischemic stroke (AIS) is the most common type of stroke, which has high rate of morbidity, mortality and disability. A large number of studies have confirmed that the thrombolytic therapy can effectively open blood vessels and improve the functional prognosis of acute ischemic stroke. Therefore, all guidelines recommend intravenous thrombolysis as the first treatment of ischemic stroke patients within 4.5 hours of onset. However, about 1/3 patients receiving thrombolysis will have good prognosis, while a large number of patients will still be disabled and even dead. How to improve the neurological prognosis of thrombolytic patients has been a hot topic in the world.

Recent studies have found that the combined application of argatroban and rt-PA in the treatment of AIS might improve the clinical prognosis and not significantly increase bleeding. Some studies have reported that the combined application of argatroban and rt-PA could improve the blood vessel opening rate, and prevent re-occlusion after opening.

Based on the discussion, the present study is designed to explore the efficacy and safety of argatroban plus rt-PA in the treatment of AIS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 808
• Est. completion date: January 30, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 18-80 years old;

2. Time from onset to treatment =4.5 hours;

3. NIHSS = 6

4. Diagnosis of ischemic stroke

5. Signed informed consent by patient self or legally authorized representatives.

Exclusion Criteria:

1. mRS=2;

2. History of stroke within 3 months;

3. History of intracranial hemorrhage;

4. Suspected subarachnoid hemorrhage;

5. Intracranial tumour, vascular malformation or arterial aneurysm;

6. Major surgery within 1 month;

7. Systolic pressure =180 mmHg or diastolic pressure =110 mmHg;

8. Platelet count < 105/mm3;

9. Heparin therapy or oral anticoagulation therapy within 48 hours;

10. Abnormal APTT;

11. Thrombin or Xa factor inhibitor;

12. Severe disease with a life expectancy of less than 3 months;

13. Blood glucose < 50 mg/dL (2.7mmol/L);

14. Patients who have received any other investigational drug or device within 3 months;

15. Pregnancy;

16. Researchers consider patients inappropriate to participate in the registry.

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Drug:
• rt-PA
Intravenous throbolysis with 0.9mg/kg rtPA
• Argatroban
100 ug/kg bolus over 3 to 5 minutes was administered intravenously, followed by a continuous Argatroban infusion of 1.0 ug/kg per minute for 48 hours adjusted to a target activated partial thromboplastin time of 1.75 X baseline (about 10%)

Locations

Country	Name	City	State
China	General Hospital of ShenYang Military Region	ShenYang

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of mRS (0-1)		90±7 days
Secondary	Proportion of mRS (0-2)		90±7 days
Secondary	proportion of more than 2 decrease in NIHSS score	NIHSS, National Institute of Health stroke scale	48 hours
Secondary	proportion of early neurological deterioration	Early neurological deterioration, defined as more than 4 increase in National Institute of Health stroke scale score	48 hours
Secondary	Vascular Events	The occurence of stroke or other vascular events	90±7 days
Secondary	symptomatic intracranial hemorrhage		48 hours